ULTRASONIC ENDOVASCULAR CATHETER WITH A CONTROLLABLE SHEATH
An apparatus for performing an endovascular procedure using ultrasonic energy includes a catheter with a proximal end portion and a distal end portion. The distal end portion includes a first window, which may expose a wave guide for delivering the ultrasonic energy for performing the endovascular procedure. A cover may be provided for selectively covering the window. By selectively controlling the position of the sheath, the transmission of ultrasonic energy may be regulated accordingly for providing a desired treatment regimen.
This document relates generally to the art of endovascular procedures and, more particularly, to an endovascular catheter using ultrasonic energy to perform a medical procedure, such as an atherectomy or crossing an occlusion, using a controllable sheath.
BACKGROUNDUltrasonic catheters have been proposed. An example of such a catheter is shown in U.S. Pat. No. 7,540,852, the disclosure of which is fully incorporated herein by reference. While this catheter achieves the desired result of providing enhanced disruption of blood vessel obstructions, the present disclosure proposes certain modifications or improvements to enhance the results achieved during an endovascular procedure in terms of clearing an obstruction from a vessel (such as, for example, an atherectomy for removing atherosclerosis from a blood vessel, or for crossing an occlusion).
SUMMARYAccording to a first aspect of the disclosure, an apparatus for performing an endovascular procedure using ultrasonic energy. The apparatus comprises a catheter including a proximal end portion and a distal end portion having a first window, which may be elongated in a longitudinal direction of the catheter. A wave guide is provided for delivering the ultrasonic energy for performing the endovascular procedure. A cover is also provided for selectively covering the window.
In one embodiment, the distal end portion of the catheter includes an opening through which the wave guide may pass. The catheter may comprise a first sheath including the first window. The cover may comprise a rotatable second sheath for covering the first window of the first sheath. The second sheath may include a second window for aligning with the first window, as well as an opening through which the wave guide may pass.
According to a further aspect of the disclosure, an apparatus for performing an endovascular procedure is provided. The apparatus includes a source of ultrasonic energy, and a wave guide for delivering the ultrasonic energy for performing the endovascular procedure. A catheter is provided for receiving the wave guide. The catheter includes a first window for transmitting ultrasonic energy from the wave guide and an opening at a distal end through which the wave guide may pass.
In one embodiment, a cover is provided for selectively covering the first window, which may be elongated in a longitudinal direction of the catheter. The catheter may comprise a first sheath including the window, and the cover may comprise a rotatable second sheath for covering the window of the first sheath. The second sheath may include a second window for aligning with the window of the first sheath. The second sheath may further include an opening through which the wave guide may pass.
Still a further aspect of the disclosure pertains to an apparatus for performing an endovascular procedure using ultrasonic energy. The apparatus comprises a wave guide for delivering the ultrasonic energy for performing the endovascular procedure. A catheter is adapted for selectively blocking or transmitting the ultrasonic energy from the wave guide.
In one embodiment, the catheter comprises a first window for exposing a portion of the wave guide. A cover is also provided for covering the first window. The catheter may comprise a first sheath including the first window and a second sheath forming the cover. The second sheath may also comprise a second window corresponding to the first window. One or both of the first and second sheaths may be rotatably mounted to the catheter. A source connected to the catheter may supply ultrasonic energy to the wave guide.
The accompanying drawing figures incorporated herein and forming a part of the specification, illustrate several aspects of the ultrasonic endovascular catheter with a controllable sheath and, together with the description, serve to explain certain principles thereof. In the drawing figures:
Reference will now be made in detail to the presently disclosed embodiments of the inventive aspects of the ultrasonic endovascular catheter with a controllable sheath, examples of which are illustrated in the accompanying drawing figures.
DETAILED DESCRIPTIONUltrasound or ultrasonic catheters provide for disruption of occlusions in blood vessels, such as for example, plaques, clots, lesions, or like objects that hinder blood flow. Catheters generally include a catheter body (shaft), an ultrasonic energy transmission member disposed within the catheter body and a distal head coupled with the energy transmission member and disposed at or near the distal end of the catheter body. The ultrasonic wave guide transmits ultrasonic energy from an ultrasonic transducer to the distal end of the catheter, causing it to vibrate and, thus, disrupt, dissolve, or debulk vascular occlusions (which procedures are generally called atherectomies or thrombectomies). A number of improved features of such an ultrasonic catheter are outlined more fully in the following description.
Referring now to
Catheter 10 further includes an ultrasonic wave guide (or “core wire”—not shown in
In addition to proximal connector 12, ultrasonic catheter 10 may include one or more other various components, such as a Y-connector 11 including a fluid inlet port 17 (or aperture) for passage of irrigation fluid. Inlet port 17 may be removably coupled with an irrigation tube 24, which in one embodiment may be coupled with a fluid refrigerator 30. The refrigerator 30 may, in turn, be coupled with a fluid container 32 via a connector tube 34. This arrangement may be used for introducing one or more fluids into catheter 10. Fluid may be used to cool any part of the device, such as the ultrasonic wave guide, thus helping reduce wear and tear on the catheter 10. In some embodiments, fluid inlet port 17 is located farther proximally on proximal connector 12, to allow fluid to be applied within connector 12. In some embodiments, refrigerated fluid is used, while in other embodiments irrigation fluid may be kept at room temperature. In various embodiments, oxygen supersaturated fluid, lubricious fluid, or any other suitable fluid or combination of fluids may be used, and again, such fluids may be refrigerated or kept room temperature. In an alternative embodiment to that shown in
Generally, catheter 10 may include any suitable number of side-arms or ports for passage of a guidewire, application of suction, infusing and/or withdrawing irrigation fluid, dye and/or the like, or any other suitable ports or connections. Also, ultrasonic catheters 10 per the disclosure may be used with any suitable proximal devices, such as any suitable ultrasonic transducer 14, energy source 16, coupling device(s) and/or the like. Therefore, the exemplary embodiment shown in
Referring now to
Referring now to
Catheter 110 also includes a proximal housing 112 (or “proximal connector”), having an inner bore 144 (or “inner cavity”) in which sonic connector 152, a portion of ultrasonic wave guide 140 and one or more vibration absorbers 150 reside. Housing 112 is coupled with a Y-connector 111, which includes a fluid inlet port 117 (or aperture), and Y-connector 111 is coupled with catheter body 127.
In various embodiments, housing 112 may suitably include one or more surface features 142 for increasing the overall surface area of the outer surface of housing 112. Increased surface area enhances the ability of housing 112 to dissipate heat generated by ultrasonic wave guide 140 out of catheter 110. Surface features 142 may have any suitable size or shape, such as ridges, jags, undulations, grooves or the like, and any suitable number of surface features 142 may be used. Additionally, housing 112 may be made of one or more heat dissipating materials, such as aluminum, stainless steel, any other conductive metal(s), or any suitable non-metallic conductive material(s).
In most embodiments, ultrasonic wave guide 140, such as wire, extends longitudinally through a lumen of catheter body 127 to transmit ultrasonic energy from an ultrasonic transducer 14 (not shown in
Ultrasonic wave guide 140 typically passes from a sonic connector 152, through bore 144 and Y-connector 111, and then through catheter body 127. Fluid inlet port 117 is in fluid communication with a lumen in Y-connector, which is in fluid communication with a lumen extending through catheter body 127. Thus, fluid introduced into fluid inlet port 117 is typically free to flow into and through catheter body 127 to contact ultrasonic wave guide 140. Fluid may flow out of catheter body 127 through apertures in the distal head (not shown) or through any other suitable apertures or openings, such as apertures located in catheter body 127 itself. Any suitable fluid may be passed through fluid inlet port 117 and catheter body 127, such as refrigerated fluid, lubricious fluid, super-saturated saline or contrast/saline mixture, or the like. Cooling and/or lubricating ultrasonic wave guide 140 may reduce friction and/or wear and tear of ultrasonic wave guide 140, thus prolonging the useful life of ultrasonic catheter 110 and enhancing its performance.
Referring now to
The sheath 127a may also include a lateral or side opening, such as a window 127b, adjacent to a portion of the wave guide 140, and thus exposing it to the interior of a lumen or vessel when positioned therein. As indicated in
To allow for an enhanced level of control, the window 127b may also be selectively blocked. This may be achieved by providing a cover 128 for selectively covering the opening or window 127b in the sheath 127a. As indicated in
Thus, as indicated in
When it is desired to allow for ultrasonic energy to be transmitted radially of the longitudinal axis of the catheter 110, the second sheath 128a may be rotated to align the windows 127b, 128b. This allows the energy (arrow E) to pass into the vessel through the opening thus formed, as shown in
Control of the relative rotation may be achieved at the proximal end of the catheter by providing suitable markings on the sheaths 127a, 128a to indicate the aligned position of the openings or windows 127b, 128b. The markings may be in the form of printed indicia, but may also take the form of bosses or embosses (and may be arranged to interact to create a temporary locked condition). Alternatively, radiographic visualization may be used, such as by providing one or more radiopaque markers on the periphery of the windows 127b, 128b. Alignment of the markers under fluoroscopy may indicate the aligned position of the windows.
In summary, an improved ultrasonic catheter 110 includes a controllable sheath 127a or 128a. One or both of the sheaths 127a, 128a may include windows 127b, 128b and may be adapted for relative rotation. By aligning the windows 127b, 128b to form an opening, the transmission of energy from a wave guide 140 associated with the catheter 110 may result. Yet, the catheter 110 may also be used in a “crossing” mode, such as for crossing a CTO, by reorienting the sheaths 127a, 128a and thus closing the opening formed by the windows 127b, 128b and regulating the transmission of ultrasonic energy.
The foregoing description has been presented for purposes of illustration. It is not intended to be exhaustive or to limit the embodiments to the precise form disclosed. Obvious modifications and variations are possible in light of the above teachings. For instance, instead of rotatable sheaths 127a, 128a, one or both of the sheaths may be made to telescope relative to each other to selectively uncover or block the opening for transmitting energy radially from the wave guide 140. The size and shape of the opening formed by the window 127b or 128b may also be altered from what is shown in the drawings to suit a particular desire or need in terms of a treatment regimen. All modifications and variations are within the scope of the appended claims when interpreted in accordance with the breadth to which they are fairly, legally and equitably entitled.
Claims
1. An apparatus for performing an endovascular procedure using ultrasonic energy, comprising:
- a catheter including a proximal end portion and a distal end portion, the distal end portion having a first window;
- a wave guide for delivering the ultrasonic energy for performing the endovascular procedure; and
- a cover for selectively covering the first window.
2. The apparatus of claim 1, wherein the distal end portion of the catheter includes an opening through which the wave guide may pass.
3. The apparatus of claim 1, wherein the catheter comprises a first sheath including the window, and the cover comprises a rotatable second sheath for covering the first window of the first sheath.
4. The apparatus of claim 3, wherein the second sheath includes a second window for aligning with the first window.
5. The apparatus of claim 3, wherein the second sheath includes an opening through which the wave guide may pass.
6. The apparatus of claim 1, wherein the first window is elongated in a longitudinal direction of the catheter.
7. An apparatus for performing an endovascular procedure, comprising:
- a source of ultrasonic energy;
- a wave guide for delivering the ultrasonic energy for performing the endovascular procedure; and
- a catheter for receiving the wave guide, the catheter including a first window for transmitting ultrasonic energy from the wave guide and further including an opening at a distal end through which the wave guide may pass.
8. The apparatus of claim 7, further including a cover for selectively covering the first window.
9. The apparatus of claim 8, wherein the catheter comprises a first sheath including the first window, and the cover comprises a movable second sheath for selectively blocking or covering the first window of the first sheath.
10. The apparatus of claim 9, wherein the second sheath includes a second window for aligning with the first window of the first sheath.
11. The apparatus of claim 9, wherein the second sheath includes an opening through which the wave guide may pass.
12. The apparatus of claim 7, wherein the window is elongated in a longitudinal direction of the catheter.
13. An apparatus for performing an endovascular procedure using ultrasonic energy, comprising:
- a wave guide for delivering the ultrasonic energy for performing the endovascular procedure, the wave guide including a distal end; and
- a catheter at least partially covering the wave guide and adapted for selectively blocking or transmitting the ultrasonic energy by exposing a portion of the wave guide proximal of a distal end of the catheter.
14. The apparatus of claim 13, wherein the catheter comprises a first window for exposing the portion of the wave guide.
15. The apparatus of claim 14, further including a cover for covering the first window.
16. The apparatus of claim 15, wherein the catheter comprises a first sheath including the first window and a second sheath forming the cover.
17. The apparatus of claim 16, wherein the second sheath comprises a second window corresponding to the first window.
18. The apparatus of claim 16, wherein the first sheath is rotatably mounted to the catheter.
19. The apparatus of claim 16, wherein the second sheath is rotatably mounted to the catheter.
20. The apparatus of claim 13, further including a source connected to the catheter for supplying ultrasonic energy to the wave guide.
Type: Application
Filed: Feb 6, 2017
Publication Date: Aug 9, 2018
Patent Grant number: 10582983
Inventor: Jessica Lynn Roll Hoye (Phoenix, AZ)
Application Number: 15/425,321